TumorGlow Intraoperative Molecular Imaging (IMI)

A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)

This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Tumor, Solid
• Intervention / Treatment: Drug: Indocyanine Green

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Azra Din; Phone Number: 215-615-7980; Email: azra.din@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Azra Din, MPH; Phone Number: 215-615-7980; Email: azra.din@pennmedicine.upenn.edu
      • Contact: Email: azra.din@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients 18 years of age or older.
• Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment.
• Good operative candidate as determined by the treating physician and/or multidisciplinary team.
• Subject capable of giving informed consent.

Exclusion Criteria:

• Subject unable to participate in the consent process.
• Vulnerable population including pregnant women, prisoners, and children.
• History of uncontrolled hypertension (e.g., history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications)
• Patients with a self-reported history of iodide allergies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has not been fully studied will be enrolled: glioma, breast cancer, colon cancer, rectal cancer, head and neck cancer, pulmonary metastasectomy (colorectal mets), thymoma, ovarian cancer, prostate cancer, renal cell carcinoma, thyroid cancer, parathyroid adenoma, mesothelioma, esophageal cancer, pancreas cancer, stomach cancer.	Drug: Indocyanine Green; The investigational drug is indocyanine green, single dose between 1-5 mg/kg diluted into sterile water for intravenous (IV) injection up to 5 days prior to resection surgery. The actual dose and timing from dose to imaging will be determined based on tumor type.
Experimental: Cohort 2; Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has been fully studied will be enrolled: non-small cell lung cancer, metastatic sarcoma to the lung, brain meningioma.	Drug: Indocyanine Green; The investigational drug is indocyanine green, single dose between 1-5 mg/kg diluted into sterile water for intravenous (IV) injection up to 5 days prior to resection surgery. The actual dose and timing from dose to imaging will be determined based on tumor type.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Determine the safety of indocyanine green (all tumor types combined)	Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).	Up to 5 days
Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)	Dosing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.	Up to 5 days
Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)	Timing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.	Up to 5 days
Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)	Nodule/lesion-level and subject-level sensitivity and specificity of TumorGlow (tumor type-specific).; Sensitivity of indocyanine green = TP/(TP+FN) = (# that fluoresce and are cancer)/(# that are cancer); Specificity of indocyanine green = TN/(TN+FP) = (# that not cancer and do not fluoresce)/(# that are not cancer)	Up to 5 days
Cohort 2: Confirm the efficacy of indocyanine green used with Near Infrared (NIR) fluorescent imaging as measured by Clinically Significant Event (CSE) rate (tumor type-specific)	Clinically Significant Event (CSE) rate (tumor type-specific). A CSE includes any of the following event: One or more primary nodule (cancerous or non-cancerous) not detected under normal light and/or palpation but is detected by imaging,; One or more cancerous synchronous lesion not detected under normal light and/or palpation but is detected by imaging,; The identification of a cancer positive margin that fluoresces within (less than or equal to) 5 mm of the surgical margin.	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)	Nodule/lesion-level and subject-level sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific).	Up to 5 days
Cohort 1: Provide preliminary estimate of the efficacy of indocyanine green for locating additional cancers and missed surgical margins as measured by CSE rate (tumor type-specific)	Clinically Significant Event (CSE) rate (tumor type-specific).	Up to 5 days
Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)	Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).	Up to 5 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): January 14, 2027

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indocyanine Green
• Other Study ID Numbers: 844554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No